An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA

Rheumatoid Arthritis Clinical Trial

Official title:

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02557295
• Other study ID #: CT-P13 4.2
• Status: Terminated
• Start date: December 17, 2013
• Est. completion date: March 2, 2020

Study information

• Verified date: May 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Description:

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 248
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients

2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Exclusion Criteria:

1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.

2. Patients with a current or past history of chronic infection

3. Patients with moderate or severe heart failure (NYHA class III/IV).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)	Hepatitis B virus reactivation; Congestive heart failure; Opportunistic infections (excluding tuberculosis); Serious infections including sepsis (excluding opportunistic infections and tuberculosis); Tuberculosis (TB); Serum sickness (delayed hypersensitivity reactions); Haematological reactions; Systemic lupus erythematosus/lupus-like syndrome; Demyelinating disorders; Lymphoma (not hepatosplenic T cell lymphoma); Hepatobiliary events; Hepatosplenic T cell lymphoma (HSTCL); Serious infusion reactions during a re-induction regimen following disease flare; Sarcoidosis/sarcoid-like reactions; Leukaemia; Malignancy (excluding lymphoma); Skin cancer; Pregnancy exposure; Infusion reactions associated with shortened infusion duration; Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction	Duration of study participation (up to 5 years)
Secondary	Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)	Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × vTJC28) + (0.28 × vSJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × vTJC28) + (0.28 × vSJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96; Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm); Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 < 2.6 Low Disease Activity: 2.6 = DAS28 < 3.2 Moderate Disease Activity: 3.2 = DAS28 = 5.1 High Disease Activity: 5.1 < DAS28	Day 0 ~ Week 198 (every 6 months ±6 weeks)
Secondary	Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability	The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability.; There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3.; Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.	Day 0 ~ Week 198 (every 6 months ±6 weeks)